Topic: Biomarkers

Role of Circulating Tumor DNA and Adjuvant Therapy in Urothelial Carcinoma

Role of Circulating Tumor DNA and Adjuvant Therapy in Urothelial Carcinoma

by | Jun 2023

Tyler F. Stewart, MD, discusses the groundbreaking role of circulating tumor DNA (ctDNA) in adjuvant therapy for urothelial carcinoma, highlighting its potential to revolutionize cancer treatment. ctDNA, a fragmented DNA shed by cells into the bloodstream, holds immense promise in identifying minimal residual disease and predicting patient outcomes.

Dr. Stewart emphasizes the significance of ctDNA as a biomarker and its successful application in various cancer types, including colorectal and bladder cancer. He presents studies showcasing the prognostic value of ctDNA monitoring throughout the treatment course, revealing its ability to accurately predict disease recurrence. The assay DNA methodologies, such as digital PCR and targeted capture NGS, offer remarkable sensitivity and customization to individual patients.

Dr. Stewart explores the potential of ctDNA as a predictive marker for perioperative systemic therapy, which could aid in identifying patients who would benefit most from adjuvant therapy. He highlights the positive outcomes observed in ctDNA-positive patients receiving adjuvant atezolizumab, leading to improved disease-free survival and overall survival rates.

Ongoing clinical trials, such as TOMBOLA and ImVigor011, further explore the integration of ctDNA as an essential biomarker in the management of muscle invasive bladder cancer. The extensive research on ultrasensitive ctDNA assays, novel ctDNA assays, and the use of urinary biomarkers for disease monitoring adds to the growing body of evidence supporting the clinical utility of ctDNA in cancer care.

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Bladder Sparing Tri-Modal Therapy Updates

Bladder Sparing Tri-Modal Therapy Updates

by | Feb 2023

In this 24-minute video, Daniel A. Hamstra, MD, PhD, Professor and Chair of Radiation Oncology at Baylor College of Medicine, discusses the viable but under-utilized therapy of trimodal bladder preservation. He specifically explores the role of surgery, chemotherapy, radiotherapy (RT), and check-point inhibitors in bladder sparing therapy.

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Industry Perspective – From Science to Clinical Utility: The Role of Cxbladder in the Diagnosis and Management of Bladder Cancer

Industry Perspective – From Science to Clinical Utility: The Role of Cxbladder in the Diagnosis and Management of Bladder Cancer

by | Oct 2022

In this 17-minute video sponsored by Pacific Edge Diagnostics, Tamer Aboushwareb, MD, PhD, Vice President of Medical Affairs for Pacific Edge Diagnostics, discusses the role of the Cxbladder test in improving the diagnosis, treatment, and management of bladder cancer, including lowering costs, improving physician workflow, and helping to avoid invasive cystoscopic procedures.

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Non-Muscle Invasive Bladder Cancer: Guidelines-Based Approach

by | May 2022

Raj S. Pruthi, MD, MHA, FACS, Professor in the Department of Urology at the University of California, San Francisco, reviews the American Urological Association (AUA)-Society of Urologic Oncology (SUO) guidelines on diagnosing and treating non-muscle invasive bladder cancer (NMIBC). He begins with some statistics, relating that in 2017, there were approximately 79,000 new cases of bladder cancer, 16,800 deaths, and greater than 500,000 survivors. Dr. Pruthi observes that bladder cancer is a disease of older individuals, and he predicts that the population of bladder cancer patients will increase as the population ages. He then highlights key facts about NMIBC, explaining that most patients recur, some progress, and the ability to predict recurrence and progression is based on patient-specific disease characteristics. Dr. Pruthi introduces the 2016 AUA/SUO guidelines, noting that the panel featured a patient advocate. He goes over the guidelines point by point, starting with diagnosis. Dr. Pruthi underscores the importance of performing a complete visual transurethral resection of bladder tumor (TURBT) at initial diagnosis, explaining that incomplete TURBT is a contributing factor to early recurrences. He notes that risk calculators for NMIBC are limited by lack of applicability to current populations, and also that no study has evaluated the effectiveness of urinary biomarkers to decrease mortality or improve outcomes compared with standard diagnostic methods. When discussing guidelines around treatment, Dr. Pruthi emphasizes the importance of re-resecting T1 disease since understaging occurs in about 30% of cases and patients with residual T1 (after presumed complete resection) have up to an 80% chance of progression. He also discusses guidelines around BCG administration and BCG relapse. Dr. Pruthi then looks at cystectomy, arguing that waiting until progression to muscle invasion may prove fatal. He concludes by discussing guidelines around follow up.

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Industry Perspective: Developing the Most Sensitive Urine Test for Bladder Cancer

by | Mar 2022

Nam W. Kim, PhD, Co-Founder and Chief Executive Officer & Chief Technology Officer of KDx Diagnostics, summarizes the challenges of bladder cancer diagnosis and introduces the URO17 test as an overall solution. He begins by discussing the unmet clinical need in bladder cancer for an accurate, non-invasive test due to difficult diagnosis of the disease. Dr. Kim then describes the URO17 urine test as a diagnostic that detects keratin-17 (K17) protein expression in urine cytology samples. He then reviews several studies on the efficacy of the URO17 test. Dr. Kim explains that the first study found that K17 promotes nuclear export, subsequent degradation of tumor suppressor p27 KIP1, and sustained proliferation and tumor growth by overcoming G1-S checkpoint in cancer cells. He also discusses KDx’s initial study evaluating K17 expression in bladder tissue that found that there was a significant increase in both low and high grade cancer when compared to normal tissues and showed the URO17 test to have 100% sensitivity and 96% specificity in detecting bladder cancer cells in recurrent bladder cancer patients. A study of the URO17 test’s efficacy in the hematuria population found that the test has a sensitivity of 100% and 92.6% specificity in detecting new bladder cancer. Dr. Kim concludes by describing a final study that looked at K17 expression in recurrent cancer and hematuria populations and which found similar results to the previous studies.

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Industry Perspective: The Role of URO17 ™ in the Diagnosis and Management of Bladder Cancer

Industry Perspective: The Role of URO17 ™ in the Diagnosis and Management of Bladder Cancer

by | Jun 2021

John Cucci, an executive at Acupath Laboratories, Inc., introduces the URO17TM antibody, a promising adjunct to cytology for bladder cancer diagnosis. Mr. Cucci explains that while cytology is the standard technique used in diagnosing bladder cancer and has a high positive predictive value, its sensitivity is low. URO17TM detects the expression of keratin-17, a protein strongly associated with bladder cancer, and has greater than 95% sensitivity and specificity. Mr. Cucci goes over the promising early results for URO17TM, as discussed in several papers, and notes that it has been given an expedited clinical trial process by the FDA. He also looks at its potential clinical utilization, both as a screening tool for hematuria patients and as a long-term monitoring tool for bladder cancer patients after they complete therapy. He emphasizes that URO17TM can cheaply and effectively provide additional and reliable information for the pathologist and urologist to more appropriately rule in or out additional diagnostic work-up in patients. Mr. Cucci concludes by presenting a graphic of the URO17TM diagnosis categories and risk meter.

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